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  • American Society of Clinical Oncology (ASCO)  (8)
  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 6_suppl ( 2018-02-20), p. 272-272
    Abstract: 272 Background: Prostate-specific membrane antigen (PSMA) is highly expressed in prostate cancers, making it an ideal imaging and therapeutic target of interest. The utility of the PSMA-targeted imaging agent 99m Tc-EC0652 is being evaluated, along with biomarker analysis of circulating tumor cells (CTCs), in pts with mCRPC in a PSMA-targeted chemotherapeutic study. We now report the PSMA heterogeneity via CTC vs. imaging in the pt population treated to date. Methods: Patients were enrolled in 1 of 2 cohorts: mCRPC taxane naïve or taxane exposed. A total of 48 pts evaluated at the time of the data cut had baseline CT & bone scans performed in addition to a 99m Tc-EC0652 SPECT/CT as a measure of imaging-based PSMA expression. 40 of 48 pts provided pre-treatment blood samples evaluable for CTC biomarker analysis, which included PSMA expression & were given percent homologous recombination deficiency (%HRD) scores. Four of the best and four of the worst responders were evaluated in more detail for imaging and CTC-based biomarker analysis as it related to clinical outcome. Results: 35 of 40 pts (88%) had detectable CTCs in their samples. 15 of the 35 (43%) pts had PSMA-positive CTCs. The 4 “non-responders” were on study for an average of 41 days and the 4 “responders” for an average of 256 days. Each group contained 2 taxane exposed & 2 taxane naïve patients. Of the 335 bone lesions analyzed by MDP, CT, 99m Tc-EC0652, 333 (99.4%) were characterized as PSMA pos based on their 99m Tc-EC0652 SPECT/CT scan. Of the 26 soft tissue lesions analyzed by CT, all were characterized as PSMA pos based on their 99m Tc-EC0652 SPECT/CT scan. Seven (26.9%) of those lesions were CT positive (observed on CT scan). Each group had 2 pts that were CTC-based PSMA pos & 2 that were PSMA neg . Their percent homologous recombination deficiency (%HRD) scores were of 0.60 [0.333, 1.0] for “non-responders” & 0.01 [0.0, 0.039] for “responders”. Conclusions: PSMA-based imaging showed a high percentage of positive lesions whereas CTC-based PMSA positivity is lower by comparison (43%). The discordance between the imaging results & CTC-based biomarkers, & the relative therapeutic predictive value, requires additional exploration. Clinical trial information: NCT02202447.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 4_suppl ( 2017-02-01), p. 341-341
    Abstract: 341 Background: Genomes of metastatic pancreatic cancers frequently contain intrachromosomal aberrations indicating DNA repair abnormalities associated with sensitivity to DNA damaging agents such as the platinums. Cisplatin was added to a nab-paclitaxel + gemcitabine regimen, which has been determined to improve survival over gemcitabine alone (NEJM 2013; 369:1691-1703). The objectives are to determine the efficacy and safety of nab-paclitaxel and gemcitabine plus cisplatin in patients with Stage IV pancreatic cancer. Methods: Eligibility criteria included Stage IV adenocarcinoma of the pancreas, no prior chemotherapy for systemic disease, KPS ≥ 70; life expectancy ≥ 12 weeks and measurable disease. Doses are nab-paclitaxel 125 mg/m 2 undiluted, gemcitabine 1000 mg/m 2 in 500 ml of normal saline (NS), each infused over 30 minutes on days 1 and 8 of a 21 day cycle, along with 3 different dose levels of cisplatin (25, 37.5 or 50 mg/m 2 ) in 500 ml of NS infused over 60 minutes, after the nab-paclitaxel infusion. Pre and post cisplatin hydration was given. The maximum tolerated dose and phase II dose of cisplatin is 25 mg/m 2 . Results: 25 pts were treated; 24 were evaluable (baseline and ≥ 1 follow up CT scan). The most common drug related grade (gr) 3 - 4 adverse events (AEs), n = 25, were thrombocytopenia 76% (gr 3 = 36%, gr 4 = 40%) with no serious bleeding events, anemia 32% (gr 3 = 32%, gr 4 = 0%), neutropenia 24% (gr 3 = 20%, gr 4 = 4%), infection 20% (gr 3 = 16%, gr 4 = 4%), and diarrhea 16% (gr 3 = 16%, gr 4 = 0%). Peripheral neuropathy ≥ gr 3 was seen in only 1 pt (gr 3 = 4%). Grade 5 AEs were infection (1), cardiac arrest (1), and stroke (1). Median time on therapy was 5.5 months, range (1 – 9.5). By RECIST 1.1 criteria, 2 pts had complete response (8.3%), 15 partial response (62.5%), 4 stable disease (16.7%), and 3 progressive disease (12.5%). Median overall survival to date as of 11/10/16 is 16.5 months. Conclusions: Although a small study, the high response rate and landmark evolving median survival are very encouraging. This regimen is being expanded in patients with stage IV pancreatic cancer, neoadjuvant and adjuvant settings. Clinical trial information: NCT01893801.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 4 ( 2018-02-01), p. 414-424
    Abstract: Guidelines are limited for genetic testing for prostate cancer (PCA). The goal of this conference was to develop an expert consensus-driven working framework for comprehensive genetic evaluation of inherited PCA in the multigene testing era addressing genetic counseling, testing, and genetically informed management. Methods An expert consensus conference was convened including key stakeholders to address genetic counseling and testing, PCA screening, and management informed by evidence review. Results Consensus was strong that patients should engage in shared decision making for genetic testing. There was strong consensus to test HOXB13 for suspected hereditary PCA, BRCA1/2 for suspected hereditary breast and ovarian cancer, and DNA mismatch repair genes for suspected Lynch syndrome. There was strong consensus to factor BRCA2 mutations into PCA screening discussions. BRCA2 achieved moderate consensus for factoring into early-stage management discussion, with stronger consensus in high-risk/advanced and metastatic setting. Agreement was moderate to test all men with metastatic castration-resistant PCA, regardless of family history, with stronger agreement to test BRCA1/2 and moderate agreement to test ATM to inform prognosis and targeted therapy. Conclusion To our knowledge, this is the first comprehensive, multidisciplinary consensus statement to address a genetic evaluation framework for inherited PCA in the multigene testing era. Future research should focus on developing a working definition of familial PCA for clinical genetic testing, expanding understanding of genetic contribution to aggressive PCA, exploring clinical use of genetic testing for PCA management, genetic testing of African American males, and addressing the value framework of genetic evaluation and testing men at risk for PCA—a clinically heterogeneous disease.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e19050-e19050
    Abstract: e19050 Background: It is well known HCT recipients experience multiple symptoms affecting quality of life. Emerging data supports the role palliative care can play in mitigating these issues. Our cellular therapy team collaborated with the Palliative Care team on a pilot project incorporating their expertise into the management of our new allogeneic transplant patients. We chose this group of patients given their increased needs relative to other cellular therapy recipients (i.e. autologous, CTL) and our institution’s available resources. Methods: Patients admitted to the HCT unit for allogenic stem cell transplant underwent palliative care consult during their conditioning regimen. During the initial palliative care visit, performed by a specialist palliative care nurse practitioner, patients underwent comprehensive assessment of physical symptoms, psychosocial distress, and overall quality of life. Patients were then followed during hospitalization by members of the palliative care team including Nurse Practitioner, Social Worker and Chaplain, to address identified needs and support both the patient and their family. The palliative care team provided daily communication and recommendations to our inpatient HCT team. Results: Patient one was a 61-year-old man with intermediate risk MDS who underwent a reduced intensity conditioning regimen of busulfan, fludarabine, and alemtuzumab. His transplant was complicated by delirium and anorexia. Patient two was a 63-year-old man with AML who underwent a reduced conditioning regimen of the same combination. His transplant was complicated by bone pain and insomnia. Patient three was a 70-year-old woman with AML who also underwent a reduced conditioning regimen. Her transplant was complicated by severe mucositis and gastric reflux. Conclusions: Allogeneic stem cell transplant patients experience a multitude of symptoms and psychosocial distress. With the help of a dedicated palliative care assessment, we can improve patients’ quality of life during their admission for the transplant. Considering the positive feedback from patients, we plan to conduct a formal prospective study evaluating the impact of palliative care on adult stem cell transplant patients at our institution. By addressing the patient’s whole person rather than just their disease, we also hope to decrease number of admissions as well as length of stay. Ultimately, we look forward to expanding this to other malignancies as well.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 5
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2016
    In:  Journal of Clinical Oncology Vol. 34, No. 15_suppl ( 2016-05-20), p. 4052-4052
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 15_suppl ( 2016-05-20), p. 4052-4052
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2016
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 7542-7542
    Abstract: 7542 Background: Maintenance rituximab in MCL has improved survival, though the optimal approach is not yet defined. Ibrutinib, a selective BTK inhibitor, has profound activity in R/R MCL. Ibrutinib maintenance (I-M) following induction for treatment-naive MCL has not been explored. We report preliminary results of a multicenter phase II trial assessing efficacy and safety of I-M for MCL after frontline induction. Methods: Patients with MCL with CR/PR to frontline chemo-immunotherapy (+/- autoSCT) received I-M 560 mg daily for up to 4 years. Primary objective was 3 year PFS rate. Secondary objectives were PR to CR conversions, median OS at 4 years and toxicity with MRD assessments planned. Results: Accrual is complete with 36 patients, median age of 60 (range 46-90), 28 males, 28 with advanced stage and 9 with extranodal disease. 18 (50%), 7 (19%) and 11 (31%) had low vs intermediate vs high risk MIPI respectively. 8/24 patients had a Ki-67 〉 / = 30%. For induction, 17 (47%) received BR, 18 (50%) a cytarabine-based regimen, 1 (3%) R-CHOP. 18 (50%) had autoSCT in CR1 prior to enrollment. 33 (92%) and 3 (8%) had CR and PR with induction respectively with 1 PR to CR conversion on I-M. At median follow-up of 19 mos, 24/36 (67%) patients remain on I-M (median 15 cycles, range 1-49) with 1 PD and 1 death. TRAEs led to dose reductions/interruptions in 25 (69%) patients, including permanent dose reductions in 7 (19%) and treatment discontinuation in 9 (25%; Table). 3 additional patients discontinued I-M, 1 for endometrial adenocarcinoma, 1 PD, 1 death, cause unknown. Conclusions: Ibrutinib maintenance is feasible in MCL patients who respond to frontline chemo-immunotherapy +/- autoSCT with manageable toxicities consistent with prior reports of ibrutinib. Additional follow-up and MRD status correlations with PFS and OS will provide insight on clinical relevance for this approach. Clinical trial information: NCT02242097. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2006
    In:  Journal of Clinical Oncology Vol. 24, No. 6 ( 2006-02-20), p. 904-909
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 6 ( 2006-02-20), p. 904-909
    Abstract: Black patients report lower trust in physicians than white patients, but this difference is poorly studied. We examined whether racial differences in patient trust are associated with physician-patient communication about lung cancer treatment. Patients and Methods Data were obtained for 103 patients (22% black and 78% white) visiting thoracic surgery or oncology clinics in a large Southern Veterans Affairs hospital for initial treatment recommendation for suspicious pulmonary nodules or lung cancer. Questionnaires were used to determine patients' perceptions of the quality of the physicians' communication and were used to assess patients' previsit and postvisit trust in physician and trust in health care system. Patients responded on a 10-point scale. Results Previsit trust in physician was statistically similar in black and white patients (mean score, 8.2 v 8.3, respectively; P = .80), but black patients had lower postvisit trust in physician than white patients (8.0 v 9.3, respectively; P = .02). Black patients, compared with white patients, judged the physicians' communication as less informative (7.3 v 8.5, respectively; P = .03), less supportive (8.1 v 9.3, respectively; P = .03), and less partnering (6.4 v 8.2, respectively; P = .001). In mixed linear regression analysis, controlling for clustering of patients by physician, patients' perceptions of physicians' communication were statistically significant (P 〈 .005) predictors of postvisit trust, although patient race, previsit trust, and patient and visit characteristics were not significant (P 〉 .05) predictors. Conclusion Perceptions that physician communication was less supportive, less partnering, and less informative accounted for black patients' lower trust in physicians. Our findings raise concern that black patients may have lower trust in their physicians in part because of poorer physician-patient communication.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2006
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 5038-5038
    Abstract: 5038 Background: Prostate-specific membrane antigen (PSMA) is highly expressed in prostate cancers, but not in most normal tissues, making it a potential therapeutic target. We are conducting a two-part phase 1 dose escalation/expansion study of EC1169, a PSMA-targeted conjugate of the microtubule inhibitor tubulysin B hydrazide in mCRPC. The utility of the PSMA-targeted companion imaging agent 99m Tc-EC0652 is also being evaluated as a patient selection tool. The safety, efficacy, and imaging-based PSMA selection strategy are being investigated in Part A (dose escalation) and Part B (2-stage, 2-cohort expansion). Methods: Part A pts were eligible if they progressed on abiraterone or enzalutamide, and were treated with a taxane. EC1169 was administered as an IV bolus on days 1, 8 every 21 days. Part B pts are enrolled in 1 of 2 cohorts, mCRPC taxane naïve (cohort 1, 45 pts) and taxane exposed (cohort 2, 40 pts). Prior to treatment, pts undergo a 99m Tc-EC0652 SPECT scan. The primary endpoint of Part B is median radiographic progression-free survival (rPFS). Other study evaluations are OS, PSA, and CTC-based biomarkers. Results: Part A is now complete: the RP2 dose is 6.5 mg/m 2 , on the basis of non-DLT transaminitis. 20 Part A/B pts have been treated at the RP2 dose (7 taxane naïve, 13 taxane exposed). Median age is 69 (range: 59-82). Median number of cycles is 2 (range: 1-7). 10 pts (50%) reported at least 1 treatment related AE. Most treatment related AEs are Gr1 and 2; G3 thrombocytopenia, fatigue, and constipation have occurred in 1 pt each. No Grade 4 treatment related AEs have been reported. No DLT or toxicity requiring dose reductions occurred. Four taxane-exposed pts in Part B have reached their first 9 wk radiographic assessment, of which two have soft tissue disease. One of those two patients (50%) has achieved an unconfirmed RECIST PR. Conclusions: The RP2 dose of EC1169 is 6.5 mg/m 2 . EC1169 has been well tolerated in 20 pts at the RP2 dose. Imaging with 99m Tc-EC0652 suggests excellent disease localization supporting a PSMA-targeted therapeutic strategy. There is evidence of anti-tumor activity in both the dose escalation and expansion cohorts. Clinical trial information: NCT02202447.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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